title: Capecitabine and bevacizumab for non-resectable metastatic colorectal cancer patients: final results from phase II AIO KRK 0105 trial.
abstract: BACKGROUND
  Current guidelines recommend treatment with capecitabine and bevacizumab for patients (pts) with non-resectable metastatic colorectal cancer (mCRC), although clinical data in this particular patient group are lacking.
  
  
  METHODS
  Previously untreated patients with non-resectable mCRC were to receive capecitabine (1,250 mg/sqm bid d1-14 oral) and bevacizumab (7.5 mg/kg i.v.) every 3 weeks. Progression-free survival (PFS) was the primary endpoint. Secondary endpoints include overall survival (OS), objective response rate (ORR) and toxicity.
  
  
  RESULTS
  82 pts were included: 40 female, median age 70 (range 50-86). ECOG PS 0/1/2 was 38/52/10%, respectively. Synchronous metastases were present in 58 pts. 16 pts had primary tumor in situ. Median treatment duration was 4.1 months (6 cycles). Toxicity was generally mild. ORR was 38%, with 5 complete and 23 partial responses. Median PFS was 7.0 months [95% CI (5.0-9.1)] and OS 17.9 months [95% CI (14.6-21.6)]. Second- and third-line systemic therapy was given to 57% and 33% of pts, respectively.
  
  
  CONCLUSIONS
  Besides the favourable tolerability, PFS and OS were shorter than reported by other trials. Careful patient selection for upfront capecitabine and bevacizumab is essential.
authors.affiliation: Tumor Biology Center Freiburg, Breisacher Str, 117, 79106 Freiburg, Germany. arnold@tumorbio.uni-freiburg.de.
authors.forename: Alexander
authors.initials: A
authors.lastname: Stein
authors.forename: Albrecht
authors.initials: A
authors.lastname: Kretzschmar
authors.forename: Dirk
authors.initials: D
authors.lastname: Behringer
authors.forename: Thomas
authors.initials: T
authors.lastname: Wolff
authors.forename: Joachim
authors.initials: J
authors.lastname: Zimber
authors.forename: Susanna
authors.initials: S
authors.lastname: Hegewisch-Becker
authors.forename: Erika
authors.initials: E
authors.lastname: Kettner
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Pflüger
authors.forename: Andreas
authors.initials: A
authors.lastname: Kirsch
authors.forename: Dirk
authors.initials: D
authors.lastname: Arnold
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D000069287:Capecitabine; D005472:Fluorouracil